Description

Albendazole Bp Impurity K is a specified impurity of the anthelmintic drug Albendazole, as defined in pharmacopeial monographs. This high-purity reference standard is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is primarily required by pharmaceutical R&D laboratories, quality assurance/control (QA/QC) departments, and contract research organizations (CROs) to ensure drug safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Albendazole Bp Impurity K in active pharmaceutical ingredient (API) and finished drug product testing.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling of Albendazole.
• Quality Control & Assurance: Serves as a system suitability standard and for preparing calibration curves to monitor impurity levels against ICH guidelines in QA/QC laboratories.
• Regulatory Compliance & Filings: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to track the formation and level of this specific impurity during forced degradation and long-term stability testing of Albendazole formulations.
• Research & Development: Used in pharmaceutical R&D to study the degradation pathways and metabolism of Albendazole.

Basic Information

Product Name	Albendazole Bp Impurity K
CAS No.	70484-51-4
Molecular Formula	C12H15N3O2S
Molecular Weight	265.33 g/mol
Synonyms	Albendazole Impurity K; Albendazole EP Impurity K; Albendazole Related Compound K; Methyl [5-(propylthio)-1H-benzimidazol-2-yl]carbamate; 5-(Propylthio)-2-carbomethoxyaminobenzimidazole; Albendazole Sulfoxide Impurity; (5-(Propylthio)-1H-benzo[d]imidazol-2-yl)carbamic acid methyl ester
EINECS	Contact for details

Quality Control

Our Albendazole Bp Impurity K is manufactured and tested under strict quality systems. Each batch is characterized using advanced analytical techniques including HPLC, GC, MS, and NMR to confirm identity and purity, ensuring it meets the stringent requirements for use as a pharmaceutical reference standard. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and identification.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.